Digital stethoscope company Eko has received FDA clearance for its artificial intelligence-powered algorithms to help detect heart conditions such as murmurs and atrial fibrillation during a routine physical.
“Our vision since day one has been to build seamless technology that helps providers more accurately detect heart disease, the leading killer in the world, by putting the ears of a cardiologist in any clinician’s stethoscope,” Eko co-founder and CEO Connor Landgraf said in a statement.
The afib and heart murmur offerings represent the first in the company’s plans to provide a full suite of automated cardiac screening tools. Last month, Eko received a breakthrough designation from the FDA for an electrocardiogram-based algorithm for spotting low ejection fraction as a sign of heart failure.
According to Eko, its AI algorithm can detect afib arrhythmias with 99% sensitivity and 97% specificity using its Duo stethoscope. First cleared in June 2017, the device captures heart sounds alongside a one-lead ECG during a standard doctor’s office exam. It’s also able to uncover difficult-to-hear murmurs with a sensitivity and specificity of 87%, which can be a sign of a faulty heart valve.
These asymptomatic conditions often go unseen during an annual physical, the company said. The algorithm also measures heart rate and QRS duration, and can identify cases of tachycardia and bradycardia.
The latest clearance covers the AI’s use in adults and in conjunction with a physician’s diagnosis.
This announcement was originally featured in FierceBiotech. Read it here: https://www.fiercebiotech.com/medtech/fda-clears-eko-s-digital-stethoscope-ai-for-spotting-cases-afib-heart-murmurs
The cover image is taken from MobiHealth News who also covered this story here: https://www.mobihealthnews.com/news/north-america/fda-green-lights-ekos-heart-murmur-fib-algorithm